A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors (NCT05581004)
A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.
Who can join: Review the eligibility criteria below.
Location: Stanford University — San Francisco, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (36 Sites)
Showing the first 25 of 36 sites.
- Stanford University — San Francisco, California
- University Of Colorado — Aurora, Colorado
- Florida Cancer Specialists - Sarasota — Sarasota, Florida
- Winship Cancer Institute — Atlanta, Georgia
- Dana Farber Cancer Institute — Boston, Massachusetts
- Washington University Medical Center, Division of Oncology — St Louis, Missouri
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- The West Clinic - Memphis (Union Ave) — Germantown, Tennessee
- SCRI Oncology Partners — Nashville, Tennessee
- IDS (IDS) Pharmacist South Texas Accelerated Resear Therapeutics, LLC START — San Antonio, Texas
- Kinghorn Cancer Centre — Darlinghurst, New South Wales
- Monash Health Monash Medical Centre — Clayton, Victoria
- Linear Clinical Research Ltd — Nedlands, Western Australia
- UZ Antwerpen — Edegem,
- CHU de Liège — Herstal,
- GasthuisZusters Antwerpen — Wilrijk,
- British Columbia Cancer Agency — Vancouver, British Columbia
- Ottawa Hospital Regional Cancer Centre — Ottawa, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario
- Sir Mortimer B Davis Jewish General Hospital — Montreal, Quebec
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA — Chaïdári, Attica
- Sotiria Thoracic Diseases Hospital of Athens — Athens,
- Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis — Amsterdam,
- Universitair Medisch Centrum Groningen — Groningen,
- Seoul National University Hospital — Seoul,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Locally Advanced or Metastatic Solid Tumors
- PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors — Beverly Hills, California
- A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors — Los Angeles, California
- A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors — San Diego, California
- Study of XB010 in Subjects With Solid Tumors — Irvine, California
Explore by condition: All Locally Advanced or Metastatic Solid Tumors clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.